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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAmplia MRI CRTD DTMB1D4, DTMB1D1; Amplia MRI Quad CRT-D DTMB1QQ, DTMB1Q1; Brava CRT-D DTBC1D4, DTBC1D1, Brava Quad CRTD
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP010031
Supplement NumberS578
Date Received01/25/2017
Decision Date02/21/2017
Product Code NIK 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Additional wirebond equipment for use in hybrid manufacturing at Medtronic Tempe Campus.
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